HER-Seq: A Blood-based Screening Study to Identify Patients With HER2 Mutations for Enrollment Into Clinical Research Studies of Neratinib
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This is a multi-center, observational genomic screening protocol to identify patients whose tumors harbor somatic mutations in the ERBB2 (HER2) gene, as measured in circulating tumor DNA (ctDNA) . Patients with histologically confirmed metastatic breast cancer (MBC) or metastatic cervical cancer (MCC) are eligible for screening at 3 to 6 months intervals, or if disease progression is suspected/confirmed. Blood samples will be collected from eligible patients and ctDNA will be extracted and sequenced at a central laboratory, using HER2-targeted next generation sequencing (NGS). A certified molecular test report will be issued from the central laboratory and provided to the investigators and the study sponsor. Patients who are identified with HER2 mutations by this screening protocol will subsequently have access to an appropriate neratinib treatment protocol, pending medical eligibility.
Condition or disease
Metastatic Breast CancerMetastatic Cervical Cancer
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients with histologically-confirmed metastatic breast or metastatic cervical cancer
Women and men who are ≥18 years old at signing of informed consent
Histologically-confirmed metastatic breast or metastatic cervical cancer
Eastern Cooperative Oncology Group (ECOG) status of 0 to 2
Provide written informed consent to participate in the study and for circulating tumor DNA screening
Must be able to provide blood sample(s) for HER2 mutation testing
Breast cancer patients with known HER2+ or HER2-amplified tumors